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6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 30 [EPA-HQ-OA-2018-0259; FRL-10004-72-ORD] RIN 2080-AA14

Strengthening Transparency in Regulatory Science AGENCY: Environmental Protection Agency (EPA). ACTION: Supplemental notice of proposed rulemaking. SUMMARY: This supplemental notice of proposed rulemaking (SNPRM) includes

clarifications, modifications and additions to certain provisions published on April 30,

2018. This SNPRM proposes that the scope of the rulemaking apply to influential

scientific information as well as significant regulatory decisions. This notice proposes

definitions and clarifies that the proposed rulemaking applies to data and models

underlying both pivotal science and pivotal regulatory science. In this SNPRM, EPA is

also proposing a modified approach to the public availability provisions for data and

models that would underly significant regulatory decisions and an alternate approach.

Finally, EPA is taking comment on whether to use its housekeeping authority

independently or in conjunction with appropriate environmental statutory provisions as

authority for taking this action.

DATES: Comments must be received on or before [Insert date 30 days after date of

publication in the Federal Register]

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-OA-

2018-0259, by any of the following methods:

Federal eRulemaking Portal: https://www.regulations.gov/ (our preferred

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method). Follow the online instructions for submitting comments.

Mail: U.S. Environmental Protection Agency, EPA Docket Center, Office of

Research and Development Docket, Mail Code 28221T, 1200 Pennsylvania Avenue

NW, Washington, DC 20460.

Hand Delivery / Courier: EPA Docket Center, WJC West Building, Room 3334,

1301 Constitution Avenue, NW, Washington, DC 20004. The Docket Center’s hours of

operations are 8:30 a.m. – 4:30 p.m., Monday – Friday (except Federal Holidays).

Instructions: All submissions received must include the Docket ID No. for this

rulemaking. Comments received may be posted without change to

https://www.regulations.gov/, including any personal information provided.

FOR FURTHER INFORMATION CONTACT: Cheryl A. Hawkins, Office of Science

Advisor, Policy and Engagement (8104R), Environmental Protection Agency, 1200

Pennsylvania Ave NW, Washington, DC 20460; telephone number: (202) 564-7307;

email address: osp_staff@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

This SNPRM does not regulate any entity outside the Federal Government.

Rather, the proposed requirements would modify the EPA’s internal procedures

regarding the transparency of science underlying regulatory decisions. However, the

Agency recognizes that any entity interested in EPA’s regulations may be interested in

this proposal. For example, this proposal may be of particular interest to entities that

conduct research or another scientific activity that is likely to be relevant to EPA’s

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regulatory activity.

B. What is the Agency’s authority for taking this action?

On April 30, 2018, EPA published the Strengthening Transparency in Regulatory

Science Proposed Rulemaking (“2018 proposed rulemaking,” Ref. 1). The 2018

proposed rulemaking cites as authority several environmental statutes that EPA

administers: the Clean Air Act; the Clean Water Act; the Safe Drinking Water Act; the

Resource Conservation and Recovery Act; the Comprehensive Environmental

Response, Compensation, and Liability Act; the Federal Insecticide, Fungicide, and

Rodenticide Act; the Emergency Planning and Community Right-To-Know Act and the

Toxic Substances Control Act. Subsequently, in the Federal Register at 83 FR 24255,

May 25, 2018, EPA published a document extending the comment period and

announcing a public hearing on the 2018 proposed rulemaking to be held on July 18,

2018 (Ref. 2). That document identified 5 U.S.C. 301 as a source of authority in

addition to those statutes cited in the 2018 proposed rulemaking. With respect to the

authorities cited in the 2018 proposal, EPA is clarifying that the citation to the Resource

Conservation and Recovery Act (“RCRA”) section 7009, 42 U.S.C. 6979, should be to

RCRA section 8001, 42 U.S.C. 6981; the citation to the Comprehensive Environmental

Response, Compensation, and Liability Act (“CERCLA”) section 116, 42 U.S.C. 9616,

should be to CERCLA section 115, 42 U.S.C. 9615; and including the Clean Water Act

section 501, 33 U.S.C. 1361.

EPA is authorized to promulgate this regulation under its housekeeping authority.

The Federal Housekeeping Statute provides that “[t]he head of an Executive

department or military department may prescribe regulations for the government of his

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department, the conduct of its employees, the distribution and performance of its

business, and the custody, use, and preservation of its records, papers, and property.”

5 U.S.C. 301. As the Supreme Court discussed in Chrysler Corp v. Brown, the intended

purpose of section 301 was to grant early Executive departments the authority “to

govern internal departmental affairs.”1 As the Supreme Court further notes, section 301

authorizes “what the [Administrative Procedure Act] terms ‘rules of agency organization,

procedure or practice’ as opposed to substantive rules.”2

EPA is not one of the 15 “Executive Departments” listed at 5 U.S.C. 101.

However, EPA gained housekeeping authority through the Reorganization Plan No. 3 of

1970, 84 Stat. 2086 (July 9, 1970). The Reorganization Plan created EPA, established

the Administrator as “head of the agency” and transferred functions and authorities of

various agencies and Executive departments to EPA.

Section 2(a)(1)-(8) of the Reorganization Plan transferred to EPA functions

previously vested in several agencies and executive departments including the

Departments of Interior and Agriculture. Section 2(a)(9) also transferred so much of the

functions of the transferor officers and agencies “as is incidental to or necessary for the

performance by or under the Administrator of the functions transferred.”

The Office of Legal Counsel has opined that the Reorganization Plan “convey[s]

to the [EPA] Administrator all of the housekeeping authority available to other

department heads under section 301” and demonstrates that “Congress has vested the

Administrator with the authority to run EPA, to exercise its functions, and to issue

1 Chrysler Corp. v. Brown, 441 U.S. 281, 309 (1979). 2 Id. at 310.

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regulations incidental to the performance of those functions.”3

Courts have considered EPA to be an agency with section 301 housekeeping

authority. The U.S. Court of Appeals for the Second Circuit, in EPA v. General Elec.

Co., 197 F.3d 592, 595 (2d Cir. 1999), found that “the Federal Housekeeping Statute, 5

U.S.C. 301, authorizes government agencies such as the EPA to adopt regulations

regarding ‘the custody, use, and preservation of [agency] records, papers, and

property.’” The Fourth Circuit Court of Appeals, in Boron Oil Co. v. Downie, 873 F.2d 67,

69 (4th Cir. 1989), held that the district court exceeded its jurisdiction where it

compelled testimony contrary to duly promulgated EPA regulations which EPA argued

were authorized by section 301.

EPA’s housekeeping authority was established by the Reorganization Plan. As

indicated by the case law and the OLC Opinion, it has long been recognized that EPA

has been granted full section 301 or equivalent authority. Therefore, EPA has ample

authority to promulgate regulations that govern internal agency procedures.

The 2018 proposed rulemaking, as supplemented by this SNPRM and this

accompanying preamble, describes how EPA will handle studies when data and models

underlying science that is pivotal to EPA’s significant regulatory decisions or influential

scientific information are or are not publicly available in a manner sufficient for

independent validation and analysis. The rule would not regulate the conduct or

determine the rights of any entity outside the federal government.4 Rather, it exclusively

3 Authority of EPA to Hold Employees Liable for Negligent Loss, Damage, or Destruction of Government Personal Property, 32 O.L.C. 79, 2008 WL 4422366 at *4 (May 28, 2008) (“OLC Opinion”) 4 See also United States v. Manafort, 312 F. Supp. 3d 60, 75 (D.D.C. 2018) (explaining that the Department of Justice “was not at all ambiguous about what it was doing when it promulgated the Special Counsel Regulations [under the authority of 5 U.S.C. 301], and it emphasized that it was not creating a substantive rule.”).

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pertains to the internal practices of the EPA.

Finally, EPA in the 2018 proposed rulemaking, as supplemented by this SNPRM

and this accompanying preamble, does not propose to interpret provisions of a

particular statute or statutes that it administers. Instead, in this action, EPA proposes a

rule of agency procedure to establish an agency wide approach to handling studies

when the data and models underlying EPA’s significant regulatory decisions and

influential scientific information are publicly available and when those data and models

are not publicly available. Therefore, this is a proposed internal rule of agency

procedure.

This internal agency procedure is intended to be consistent with the statutes that

EPA administers and EPA plans to implement this procedural rulemaking in accordance

with all applicable statutory and regulatory requirements. Indeed, as discussed in this

SNPRM, EPA is also proposing options that would allow EPA to consider studies even if

the underlying data and models are not publicly available. [See Section IV.] The Agency

seeks comment on whether this approach may improve consistency between this

proposed rulemaking and certain provisions of those statutes that refer to standards for

data availability. Nonetheless, in the event the procedures outlined in the proposed

rulemaking conflict with the statutes that EPA administers, or their implementing

regulations, the statutes and regulations will control. Moreover, EPA is considering how

to proceed, apart from this supplemental proposal, to establish regulations interpreting

provisions of, and/or exercising substantive rulemaking authority delegated to it by

programmatic statutes, to include one or more of those statutes cited as authority in the

2018 proposed rulemaking as clarified in this SNPRM.

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Although this is a rule of internal agency procedure and EPA does not propose to

interpret provisions of a particular statute or statutes that it administers, EPA is taking

comment on whether to use its housekeeping authority independently as authority or in

conjunction with the environmental statutory provisions cited as authority in the 2018

proposed rulemaking (as clarified in this SNPRM). The Agency continues to consider

whether it is appropriate to rely on its authority in the above-reference environmental

statutory provisions (potentially in conjunction with its housekeeping authority). The

Agency will consider comments on this issue submitted in response to the 2018

proposal and in response to this SNPRM.

C. What action is the Agency taking?

EPA is issuing this SNPRM to clarify, modify and supplement certain provisions

included in the 2018 proposed rulemaking in response to some of the public comments

received on the 2018 proposed rulemaking (83 FR 18768), as well as to ensure

consistency with the April 2019 release of the White House’s Office of Management and

Budget (OMB) Memorandum to the Heads of Executive Departments and Agencies

entitled Implementation of the Information Quality Act (OMB M-19-15, Ref. 3). This

memorandum is directly relevant to several of the provisions of the 2018 proposed

rulemaking because it updates implementation of OMB’s 2002 Guidelines for Ensuring

and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated

by Federal Agencies to, among other things, reflect recent innovations and policies

surrounding information access.

First, EPA is modifying the regulatory text initially proposed in the 2018 proposed

rulemaking at 40 CFR 30.3, 30.5, 30.6 and 30.9 so that these provisions would apply to

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data and models, not only dose-response data and dose-response models. In addition,

EPA is clarifying that the use of the terms “model assumptions” and “models” in the

proposed regulatory text at 40 CFR 30.6 apply to the assumptions that drive the model’s

analytic results. EPA has modified the regulatory text at 40 CFR 30.6 to reflect this

clarification. This approach is consistent with OMB M-19-15 (Ref. 3), which highlights

the need to characterize the sensitivity of an agency’s conclusions to analytic

assumptions.

Second, EPA is proposing to expand the scope of this rulemaking to apply to

influential scientific information5,6 as well as significant regulatory actions. EPA is

proposing to add definitions for “influential scientific information” and “pivotal science” at

40 CFR 30.2 that will pertain to the science underlying influential scientific information,

which are not regulatory, and is making conforming changes to proposed 40 CFR 30.3,

30.5, 30.6 and 30.7. EPA is retaining the definition of “pivotal regulatory science” from

the 2018 proposed rulemaking regulatory text.

Third, EPA is modifying, deleting and proposing new regulatory text in addition to

proposing definitions for “influential scientific information” and “pivotal science” at

proposed 40 CFR 30.2. EPA is deleting the first paragraph of the 2018 proposed

rulemaking regulatory text at 40 CFR 30.2. EPA is deleting the definition of “research

data” at 40 CFR 30.2. EPA is proposing definitions for the terms “capable of being

5 The term “influential scientific information” means scientific information the agency reasonably can determine will have or does have a clear and substantial impact on important public policies or private sector decisions (OMB M-05-03). A “highly influential scientific assessment” is a subset of influential scientific information and refers to “an evaluation of a body of scientific or technical knowledge that typically synthesizes multiple factual inputs, data, models, assumptions, and/or applies best professional judgment to bridge uncertainties in the available information” and that the dissemination of such assessment could have “a potential impact of more than $500 million in any one year on either the public or private sector or that the dissemination is novel, controversial, or precedent-setting, or has significant interagency interest” (OMB M-05-03). 6 See EPA’s Peer Review Agenda at https://cfpub.epa.gov/si/si_public_pr_agenda.cfm

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substantially reproduced,” “data,” “independent validation,” “model,” “publicly available,”

and “reanalyze.” These revisions are intended to provide clarity on key terminology

used in the regulatory text in the 2018 proposed rulemaking as well as in this

supplemental proposal.

Fourth, EPA is deleting the 2018 proposed regulatory text at 40 CFR 30.10. This

change is being made to be consistent with the deletion of “research data” in 40 CFR

30.2 because 40 CFR 30.10 would have required EPA to implement this rulemaking to

be consistent with the definition of “research data.” With the deletion of “research data”

from proposed 40 CFR 30.2, proposed 40 CFR 30.10 is no longer needed.

Fifth, EPA is proposing a modified version of the regulatory text at 40 CFR 30.5

from that proposed in the 2018 proposed rulemaking. Under this new approach to

proposed 40 CFR 30.5, when promulgating significant regulatory decisions or finalizing

influential scientific information, the Agency will only use pivotal regulatory science

and/or pivotal science if the data and models are available in a manner sufficient for

independent validation. This includes studies with data and models that are publicly

available as well as studies with restricted data and models (i.e., those that include

confidential business information (CBI), proprietary data, or Personally Identifiable

Information (PII) that cannot be sufficiently de-identified to protect the data subjects) if

there is tiered access to these data and models in a manner sufficient for independent

validation. Tiered access includes the appropriate techniques used to reduce the risk of

re-identification and, therefore, mitigate certain disclosure privacy risks associated with

providing such access.

As an alternative, EPA is proposing that under proposed 40 CFR 30.5, when

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promulgating significant regulatory decisions or finalizing influential scientific

information, other things being equal, the Agency will give greater consideration to

studies where the underlying data and models are available in a manner sufficient for

independent validation either because they are publicly available or because they are

available through tiered access when the data includes CBI, proprietary data, or PII that

cannot be sufficiently de-identified to protect the data subjects. The Agency will identify

those studies that are given greater consideration and will provide a short description of

why greater consideration was given. As discussed later in the preamble, such

approaches to increasing access to data and models can often allow stakeholders to

reanalyze the data and models and explore the sensitivity of the conclusions to

alternative assumptions while accessing only the data and aspects of the models that

they need. This proposal would apply to reviews of data, models, and studies at the

time a rule is developed or influential scientific information is finalized, regardless of

when the data and models were generated. See Section IV of this preamble for a

description of these proposals.

Sixth, EPA is modifying 40 CFR 30.9 to describe the factors the Administrator

would consider in determining whether to grant an exemption to the proposed public

availability requirements for using data and models in significant regulatory decisions

and influential scientific information.

Seventh, the EPA is proposing the option of using its housekeeping authority

independently as authority for taking this action or in conjunction with the environmental

statutory provisions cited as authority in the 2018 proposed rulemaking (as clarified in

this supplemental proposal). The Agency continues to consider whether it is appropriate

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to rely on its authority in the above-referenced environmental statutory provisions

(potentially in conjunction with its housekeeping authority). The Agency will consider

comments on this issue submitted in response to the 2018 proposal and in response to

this SNPRM. Section 301 authority as transferred to EPA in Reorganization Plan No. 3

of 1970 provides appropriate authority for EPA to promulgate regulations that govern

internal agency procedures. This action establishes internal agency procedures

governing how EPA employees will handle studies when the data and models

underlying science that is pivotal to EPA’s significant regulatory decisions and/or

influential scientific information are or are not publicly available.

The 2018 proposed rulemaking solicited comment on all aspects of the

proposed rulemaking. This SNPRM solicits comment only on the changes and additions

to the proposed regulatory text discussed in this supplemental document. Comments

submitted in response to this supplemental document that address aspects of the 2018

proposed rulemaking that are not addressed, altered, or replaced by this SNPRM will be

deemed outside the scope of this supplemental action.

D. Why is the Agency taking this action?

EPA received extensive comment on the 2018 proposed rulemaking regarding

the clarity of certain aspects of the proposed rulemaking and the challenges in making

all dose-response data and models publicly available. The intent of this supplemental

proposal SNPRM is to address certain concerns raised about the clarity of the 2018

proposed rulemaking; to clarify consistency with OMB M-19-15, OMB M-05-03 (Final

Information Quality Bulletin for Peer-Review, Ref. 4), and Executive Order 13891 (Ref.

5); to propose an alternate 40 CFR 30.5 provision for availability of data and models

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underlying pivotal regulatory science and pivotal science, and to propose relying on 5

U.S.C. 301 independently or in conjunction with the environmental statutory provisions

cited as authority in the 2018 proposed rulemaking (as clarified in this SNPRM). The

Agency continues to consider whether it is appropriate to rely on its authority in the

above-reference environmental statutory provisions (potentially in conjunction with its

housekeeping authority). The Agency will consider comments on this issue submitted in

response to the 2018 proposal rulemaking and in response to this SNPRM.

II. Applicability to data and models

As identified by some public commenters, the 2018 proposed rulemaking did not

put its discussion of increasing access to the data and models underlying pivotal

regulatory science into the context of the broader approach that EPA uses to evaluate

the entire body of scientific literature—that is, before it identifies candidates for “pivotal

regulatory science.” Under this regulation EPA would continue to use standard

processes for identifying, evaluating, and reviewing available data, models, and studies.

When the Agency has potentially identified multiple key studies or models of similar

quality that could drive its subsequent decisions, the Agency will investigate the

availability of the underlying data. If, for example, multiple high-quality studies exist but

only two studies have data and models that are available for independent validation and

reanalysis, EPA would only include those two studies as pivotal regulatory science

and/or pivotal science in accordance with the 2018 proposed rulemaking. However,

under the alternative approach in this supplemental proposal, EPA would consider using

all available high-quality studies but give greater consideration to those two studies with

data available for independent validation.

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As highlighted in some public comments, the terms “dose-response data and

models,” “dose-response models,” “models” and “model assumptions” are not used

consistently throughout the regulatory text of the 2018 proposed rulemaking. For

example, some parts of the regulatory text appear to limit applicability of certain

provisions to only dose-response models.7 In others, the requirements would apply

more broadly. EPA is now proposing a broader applicability. Transparency of EPA’s

science should not be limited to dose-response data and dose-response models,

because other types of data and models will also drive the requirements and/or

quantitative analysis of EPA final significant regulatory decisions and influential scientific

information.

EPA is modifying the proposed regulatory text at 40 CFR 30.3, 30.5, 30.6 and

30.9 by deleting the term “dose-response,” except in one instance. In proposed 40 CFR

30.6, EPA is not deleting “dose response” from the sentence specific to parametric

dose-response models. EPA is also removing “including assumptions of a linear, no-

threshold dose response” from 40 CFR 30.6, because this could imply that the

regulation is specific to those particular assumptions. This is not the intent of proposed

40 CFR 30.6.

Consistent with this broader approach to transparency, the proposed

requirements of this rule would apply broadly to data and models underlying pivotal

regulatory science and pivotal science which support significant regulatory decisions

and influential scientific information, respectively, rather than simply to dose-response

data and models. Some, but not the only, examples of information that would be

7 See § 30.6

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considered to be data and models, in addition to dose-response data and dose-

response models, include environmental fate studies, bioaccumulation data, water-

solubility studies, environmental fate models, engineering models, data on

environmental releases, exposure estimates, quantitative structure activity relationship

data, and environmental studies. The proposed definitions of “data” and “models” are

discussed more fully in Section III.B of this preamble.

In addition, EPA is clarifying that the use of the terms “model assumptions” and

“models” in the proposed regulatory text at 40 CFR 30.6 apply to the assumptions that

drive the model’s analytic results, not to each model assumption used in the model.

EPA has modified the regulatory text at 40 CFR 30.6 to reflect this clarification.

EPA requests comment on the applicability of proposed 40 CFR 30.3, 30.5, 30.6

and 30.9 to data and models.

III. Definitions

A. “Reanalyze” and “independent validation.”

To improve the clarity of the proposed requirements, EPA is proposing definitions

for certain terms.

In the 2018 proposed rulemaking, EPA used the terms “replicate” and

“reproducible” and related terms. “Replicate” is used in the proposed regulatory text at

40 CFR 30.5. That section reads, in pertinent part, “[I]nformation is considered ‘publicly

available in a manner sufficient for independent validation’ when it includes the

information necessary for the public to understand, assess, and replicate findings…”

“Replication” and “reproducibility” are both used in the 2018 proposed rulemaking

preamble though neither is defined. Neither “reproducibility” nor its cognates are used

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in the regulatory text. “Replicate” was used but not defined in the regulatory text and its

meaning was not discussed in the preamble.

Commenters contended that EPA was not clear about what it meant by the term

“replicate” and that EPA appears to have conflated the term with “reproducible.”

Commenters interpreted the term “replicate” in several different ways. For example,

some commenters contended that EPA used the term “replicate” but actually meant

“reanalyze.” EPA finds that these comments have merit and has determined that the

intent of the term “replicate” should be clarified by establishing a regulatory definition.

EPA has considered the definitions in the National Academy of Sciences (NAS)

“Principles and Obstacles for Sharing Data from Environmental Health Research.” (Ref.

6, NAS Workshop Report), Pellizzari, et al. “Reproducibility: A Primer on Semantics

and Implications for Research” (Ref. 7), and Goodman, et al. “What does research

reproducibility mean?” (Ref. 8). As demonstrated by these documents, there are

varying definitions and understandings of these terms in the scientific community.

Several commenters pointed to the use of the terms in the NAS Workshop Report (Ref.

6). The definitions in the NAS Workshop Report (Ref. 6) define “reanalysis,”

“replication,” and “reproduce” as follows:

A reanalysis is when you conduct a further analysis of data. A person doing a reanalysis of data may use the same programs and statistical methodologies that were originally used to analyze the data or may use alternative methodologies, but the point is to analyze exactly the same data to see if the same result emerges from the analysis. Replication means that you actually repeat a scientific experiment or a trial to obtain a consistent result. The second experiment uses exactly the same protocols and statistical programs but with different data from a different population. The goal is to see if the same results hold with data from a different population. When you reproduce, you are producing something that is very similar to that research, but it is in a different medium or context. In other words, a researcher who is reproducing an experiment addresses the same research question but from a different angle than the original researcher did.

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EPA’s use of “replicate” in the proposed regulatory text at 40 CFR 30.5 in the 2018

proposed rulemaking is generally consistent with the NAS Workshop Report (Ref. 6)

definition of “reanalysis.” However, as illustrated by Refs. 4-6, and in the public

comments EPA received on the 2018 proposed rulemaking, these terms are not

consistently used or defined in the scientific literature. EPA now proposes to use the

term “reanalyze” instead of “replicate” in 40 CFR 30.5 and is clarifying the intent of the

proposed regulation by proposing a definition of “reanalyze” at proposed 40 CFR 30.2

as “to analyze exactly the same data to see if the same result emerges from the

analysis by using the same or different programs and statistical methodologies that

were originally used to analyze the data.” In addition to identifying potential analytical

errors in the original work, reanalyzing the data would allow assessment of the

robustness of the original analysis and conclusions by, for instance, showing the

variability that can occur when a previously omitted variable is added to the statistical

model, different functional form assumptions are made (e.g., a linear marginal effect of

treatment), or different assumptions are made when estimating standard errors and

drawing statistical inferences (e.g., allowing for spatial correlation in error terms).

In the 2018 proposed rulemaking, EPA did not define “independent validation.”

The definition of “independent validation” depends on how the term “reanalyze” is

defined. Independent validation for a scientific study that is being repeated by

conducting a second scientific study would be different than independent validation

where the data underlying a study is being reanalyzed to determine if the same results

can be obtained. Thus, consistent with the proposed definition of “reanalyze” at

proposed 40 CFR 30.2, EPA is proposing to define “independent validation” as the

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reanalysis of study data by subject matter experts who have not contributed to the

development of the original study to demonstrate that the same analytic results are

capable of being substantially reproduced. “Capable of being substantially reproduced”

means that independent analysis of the original or supporting data using identical

methods would generate similar analytic results, subject to an acceptable degree of

imprecision or error.

EPA’s interpretation of “capable of being substantially reproduced” as included in

the proposed definition above builds on the description in the “Guidelines for Ensuring

and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated

by Federal Agencies” (Ref. 9). These guidelines, which were issued by the Office of

Management and Budget, are intended to help agencies ensure and maximize the

quality, utility, objectivity and integrity of the information that they disseminate.

EPA is requesting comment on the proposed definitions of “reanalyze” and

“independent validation” at proposed 40 CFR 30.2.

B. Data and models.

Given the use of the term “data and models” in proposed 40 CFR 30.3, 30.5,

30.6 and 30.9 as described in Section II of this preamble, EPA is proposing to define

“data” and “models” at proposed 40 CFR 30.2. EPA proposes to broaden the scope of

the proposal by deleting the modifying term “dose-response,” as indicated above, so as

to extend the reference to data and models underlying pivotal regulatory science and

pivotal science used to support significant regulatory decisions and influential scientific

information, respectively, not simply dose-response data and dose-response models.

Examples of information that would be considered to be data and models for purposes

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of the proposed rulemaking include environmental fate studies, bioaccumulation data,

water-solubility studies, environmental fate models, engineering models, data on

environmental releases, exposure estimates, quantitative structure activity relationship

data, and environmental studies. This list is not exhaustive but is intended to provide

examples of the range of information that would be considered to be within the scope of

data and models.

1. Data and research data. Data has been defined to mean, in part, the recorded

factual material commonly accepted in the scientific community as necessary to validate

research findings (Ref. 10). As noted by public commenters and in the NAS Workshop

Report (Ref. 6), there are different stages of these data. “There are raw data, which

come straight from the survey or the experiment. There are cleaned-up data, which

consist of the raw data modified to remove obvious errors.” (These are the data that are

ready to be analyzed to extract relevant information.) “There are processed data, which

are data that have been computed and analyzed to extract relevant information. There

is the final clean data set that is provided with a publication. And there are the metadata

that describe the data” (Ref. 6). These different data sets or stages of data may be

used for different purposes and in different contexts.

The Agency received comment asking EPA to clarify what stage of data would

need to be publicly available to allow for independent validation. Thus, EPA is

incorporating the concept of stage of data with the basic concept of research data as

“recorded factual material commonly accepted in the scientific community as necessary

to validate research findings” from its definition at 2 CFR 200.315. For purposes of

independent validation through reanalysis, the stage of data would be the cleaned-up or

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analyzable data set in which obvious errors have been removed. Obvious errors do not

include data that could be characterized as outliers. These data are the cleaned-up or

analyzable data set (Ref. 6). Therefore, EPA is proposing to define “data” as the set of

recorded factual material commonly accepted in the scientific community as necessary

to validate research findings in which obvious errors, such as keystroke or coding

errors, have been removed and that is capable of being analyzed by either the original

researcher or an independent party. EPA requests comment on this proposed definition

and whether the definition of “data” should apply to another stage of data described in

Ref. 6. The focus on this later stage of data is consistent with the Federal Government’s

approach to data access, and specifically to EPA’s “2016 Plan to Increase Access to

Results of EPA-Funded Scientific Research” (Ref. 11). Finally, EPA requests comment

on whether there is another definition of “data” that should be considered.

EPA is deleting the 2018 proposed 40 CFR 30.2 definition of “research data,”

because this definition excludes “trade secrets, commercial information, materials

necessary to be held confidential by a researcher until they are published, or similar

information which is protected under law” and “[p]ersonnel and medical information and

similar information the disclosure of which would constitute a clearly unwarranted

invasion of personal privacy, such as information that could be used to identify a

particular person in a research study.” These types of data are intended to be subject

to this rulemaking. To conform with this change, EPA is deleting the 2018 proposed 40

CFR 30.10 regulatory text because it would require EPA implementation of this

rulemaking to be consistent with the definition of “research data.”

2. Model. EPA is proposing to define “model” as it is defined in EPA’s Guidance

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on the Development, Evaluation, and Application of Environmental Models (Ref. 12).

EPA’s guidance document was produced to aid in strengthening the Agency’s

development, evaluation and use of models. In this guidance document, a model is

described as “a simplification of reality that is constructed to gain insights into select

attributes of a physical, biological, economic, or social system. A formal representation

is characterized as the behavior of system processes, often in mathematical or

statistical terms. The basis can also be physical or conceptual.” This definition is based

in part on the National Research Council’s (NRC) 2007 report Models in Environmental

Regulatory Decision Making (Ref. 13). As noted by the NRC, models can be of many

different forms. They can be computational, physical, empirical, conceptual or a

combination of one or more types. EPA is requesting comment on the proposed

definition of “model” at proposed 40 CFR 30.2.

C. Publicly available.

In the 2018 proposed rulemaking, EPA used the term “publicly available” but did

not define it at 40 CFR 30.2 or in the preamble to the 2018 proposed rulemaking. Given

its use at 40 CFR 30.1, 30.5 and 30.9, EPA is proposing to define it. Publicly available

information is often defined to mean information that is made available to the general

public (e.g., see 40 CFR 2.201, 17 CFR 160.3, 16 CFR 313.3). EPA is proposing to

define it similarly to how it is defined at 16 CFR 313.3. Although the overall purpose of

the regulations at 16 CFR 313 is different than the purpose of this rulemaking, the

meaning of information that is available to the general public should not vary. This

would encompass information legally available from government sources, the media

and the Internet. EPA is requesting comment on the proposed definition of “publicly

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available” at proposed 40 CFR 30.2.

IV. Availability of Data and Models

In the 2018 proposed rulemaking, EPA proposed to require at 40 CFR 30.5 that

“[w]hen promulgating significant regulatory decisions, the Agency shall ensure that

dose-response data and models underlying pivotal regulatory science are publicly

available in a manner sufficient for independent validation.” EPA received a large

number of comments stating that the approach in the 2018 proposed rulemaking would

likely preclude the use of valid data and models from consideration as pivotal regulatory

science, because the proposed requirement to make data and models publicly available

in a manner sufficient for independent validation would prevent the use of data and

models that include CBI data, proprietary data, PII data that cannot be sufficiently de-

identified to protect the data subjects, as well as many older studies. While having

these data and models publicly available provides the greatest transparency, these

commenters expressed concern that this approach could limit the use of certain data

and models in EPA’s significant regulatory decisions. Based on a consideration of these

comments, EPA is proposing a modified version of the 2018 proposed rulemaking

regulatory text at 40 CFR 30.5. Proposed 40 CFR 30.5 would allow Agency

consideration of studies where there is tiered access to data and models that have CBI,

proprietary data, or PII that cannot be sufficiently de-identified to protect the data

subjects. For all other studies, data and models should be publicly available if the

studies are to be used as pivotal regulatory science or pivotal science.

As discussed in OMB M-19-15 (Ref. 3), risk reduction techniques include

creating multiple versions of a single dataset with varying levels of specificity and

22

protection. The benefit of tiered access is that data users who wish to conduct activities

with a statistical purpose without first obtaining special authorization have access to the

versions of the data in the least restricted tiers, allowing them to conduct research while

protecting confidentiality.

EPA is also proposing an alternative approach to today’s proposed 40 CFR 30.5.

Under alternative proposed 40 CFR 30.5, when promulgating significant regulatory

decisions or finalizing influential scientific information, the Agency will, other things

equal, give greater consideration to studies where the underlying data and models are

available in a manner sufficient for independent validation either because the

information is publicly available or available through tiered access when the data include

CBI, proprietary data, or PII and appropriate techniques have been used to reduce the

risk of re-identification. In developing the significant regulatory decision or influential

scientific information, the EPA will identify those studies that are given greater

consideration and provide a short description of why greater consideration was given.

However, the Agency may still consider studies where there is no access or limited

access to underlying data and models.

EPA is also clarifying that the Agency does not intend to make all data and

models underlying pivotal regulatory science and pivotal science publicly available.

There may be instances where EPA does not own the data and models, lacks access to

part or all of the data and models or does not have the authority to provide access to

part or all of the data and models. Rather, EPA is describing how it will handle studies

based on whether the underlying data and models are publicly available.

Both today’s proposal and alternate proposal are consistent with EPA’s

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statements in the April 2018 proposed rulemaking that “access to dose response data

and models underlying pivotal regulatory science” should be done “in a manner

consistent with statutory requirements for protection of privacy and confidentiality of

research participants, protection of proprietary data and confidential business

information, and other compelling interests” (Ref. 1). Both approaches are also based

on EPA’s recognition that there are statutory restrictions to public availability for some

data and models that could make independent validation difficult. Further, both of these

approaches are consistent with the OMB’s M-19-15 (Ref. 3). OMB’s implementation

updates direct federal agencies to “explore methods that provide wider access to

datasets while reducing the risk of disclosure of [PII]…[T]iered access offers promising

ways to make data widely available while protecting privacy” (Implementation Update

3.5, Ref. 3). In addition, “Agencies should prioritize increased access to the data and

analytic frameworks (e.g., models) used to generate influential information” while being

“consistent with statutory, regulatory, and policy requirements for protections of privacy

and confidentiality, proprietary data, and confidential business information”

(Implementation Update 3.4, Ref. 3). This proposal is also consistent with OMB

Memorandum 13-13: Open Data Policy – Managing Information as an Asset (Ref. 14).

Under a tiered approach to accessing data and models that include CBI,

proprietary data, or PII that cannot be sufficiently de-identified to protect the data

subjects, access is more restricted for more sensitive data and models. Thus, the

amount of information available for analysis is dictated by the tier. The greatest amount

of information is made available at the most restricted access tier. Access to data

involving PII would be consistent with the requirements of the Common Rule, the Health

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Insurance Portability and Accountability Act (HIPPA), the 21st Century Cures Act, the

Privacy Act, and other relevant laws and regulations, and EPA privacy policies.

Reanalyzing findings of studies based on data and models that include PII (e.g.,

residence) or CBI may not be possible given the degree of perturbation caused by de-

identification that would be needed for the information to be made publicly available.

Restricted access for researchers through secure data enclaves for PII or through non-

disclosure agreements for CBI may result in access to sufficient information about the

data and models to allow for independent validation. This ability to reanalyze findings

may be much more limited for less restricted tiers. Thus, reanalysis of findings for some

data and models may be limited to authorized researchers and not possible for the

general public.

A model of tiered access for data involving PII is the Research Data Center

(RDC), National Center for Health Statistics (NCHS), Centers for Disease Control

(CDC). The NCHS operates the RDC to allow researchers access to restricted-use

data. The RDC provides access to the restricted-use data while protecting the

confidentiality of survey respondents, study subjects, or institutions. For access to the

restricted-use data, researchers must submit a research proposal outlining the need for

restricted-use data. The submitted research proposal is intended to provide a

framework for NCHS to identify potential disclosure risks and how the data will be used

(Ref. 15). EPA is currently conducting a pilot study using the RDC’s secure data

enclave to host EPA datasets in a restricted use environment.

Development of standard data repositories is still ongoing. For example, the

White House Office of Science and Technology Policy recently solicited public

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comments on a draft set of characteristics of data repositories used to locate, manage,

share, and use data resulting from federally-funded research (85 FR 3085). The effort is

intended to help federal agencies provide more consistent information on desirable

characteristics of data repositories “for data subject to agency Public Access Plans and

data management and sharing policies, whether those repositories are operated by

government or nongovernmental entities.” Information received during this public

comment period will, among other things, help inform improved guidance and best

practices related to preserving and providing access to data.

Access to CBI data would continue to be provided consistent with the

environmental statutes EPA implements and the regulations at 40 CFR part 2, subpart

B, which govern CBI. These regulations establish basic rules governing business

confidentiality claims, how EPA handles business information that is or may be entitled

to confidential treatment, and how EPA determines whether information is entitled to

confidential treatment for reasons of business confidentiality. Various statutes under

which EPA operates contain special provisions concerning the entitlement to

confidential treatment of information gathered under such statutes. The regulations at

40 CFR part 2 subpart B prescribe rules for treating certain categories of business

information obtained under the various statutory provisions.

In accordance with these statutes, both the proposed and alternative 40 CFR

30.5 provide that access to underlying data and models that include CBI, proprietary

information, or PII, for the subset of studies that could be considered pivotal science,

may be limited to authorized officials and researchers and not provided to the general

public.

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Proposed 40 CFR 30.5 would maintain the temporal approach to data and

models taken in the regulatory text of 40 CFR 30.5 of the 2018 proposed rulemaking,

and thus would apply to data and models evaluated at the time a significant regulatory

action or influential scientific information is developed, regardless of when the data and

models were generated. EPA is requesting comment on whether this should apply only

to data and models that are generated (i.e., when the development of the data set or

model has been completed or updated) after the effective date of this rulemaking. If the

proposed or alternative approach were finalized, EPA would consider the availability of

underlying data and models only for studies that are potentially pivotal to EPA’s

significant regulatory decisions or influential scientific information that are developed in

the future.

Although the ability to independently validate pivotal regulatory science or pivotal

science is a key component of this rulemaking, EPA would like to clarify that neither the

proposed nor the alternative 40 CFR 30.5 would require that EPA, a member of the

public or other entity must independently validate a study before it can be considered to

be pivotal regulatory science or pivotal science. EPA would also like to clarify that

independent validation is not required under proposed 40 CFR 30.7 which describes the

role of independent peer review.

EPA is requesting comment on the regulatory text being proposed today for 40

CFR 30.5. For alternate proposed 40 CFR 30.5, EPA is also requesting comment on

how much consideration should be given to studies when there is limited or no access

to the underlying data and models. In addition, EPA is requesting comment on how to

ensure that, over time, more of the data and models underlying the science that informs

27

significant regulatory decisions and influential scientific information are available to the

public for independent validation in a manner that honors legal and ethical obligations to

reduce the risks of unauthorized disclosure and re-identification. Finally, EPA is

interested in comments about how to provide sufficient incentives and support to

researchers to increase access to the data that may be used as pivotal regulatory

science or pivotal science. Such comments will be used to develop implementation

guidance.

V. Exemption by the Administrator

The 2018 proposed rulemaking includes a provision at 40 CFR 30.9 allowing the

Administrator to grant exemptions from the rule on a case-by-case basis if he or she

determines that compliance is impracticable because it is not feasible to ensure that

data and models underlying pivotal regulatory science are publicly available in a manner

that is consistent with law and protects privacy and confidentiality. EPA is clarifying that

the exemption may be given if compliance is impracticable because technological

barriers render sharing of the data or models infeasible.

EPA is also modifying the scope of the data and models that can be considered

when determining whether to grant an exemption. The underlying data, models and

computer code for some studies, particularly older studies, may not be readily publicly

available because of the technological barriers to data and model sharing (e.g.,

differences in data storage devices or data retention practices) that existed when they

were developed. Thus, in 40 CFR 30.9(a), EPA is proposing to use the age of data and

models as a factor in the determination that compliance with the rule is impracticable.

This modification of scope is intended to acknowledge the evolution of best practices for

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information sharing given innovations in information generation, access, management

and use (See Ref. 3). EPA is proposing that a study or studies would be eligible for

consideration under 40 CFR 30.9(a), regardless of whether they contain CBI,

proprietary information, or PII, if the underlying data or models were collected,

completed or updated before the effective date of this rule. EPA requests comment on

this consideration of the age of data and models in determining the feasibility of making

underlying data and models publicly available. EPA also requests comment on whether

there are aspects other than the year the data or model was collected, completed or

updated that EPA should consider in determining whether to grant an exemption in

order to evaluate the technological barriers to sharing.

The 2018 proposed rulemaking also included a provision at 40 CFR 30.9

allowing the Administrator to grant exemptions from the rule on a case-by-case basis if

he or she determines that compliance is impracticable because it is not feasible to

conduct independent peer review on all pivotal regulatory science. EPA is deleting that

provision of the proposed exemption because EPA does not believe that peer review of

pivotal regulatory science or pivotal science would be infeasible. Thus, EPA no longer

believes the provision is necessary.

VI. References

The following is a listing of the documents that are specifically referenced in this

notice. The docket includes these documents and other information considered by EPA,

including documents referenced within the documents that are included in the docket,

even if the referenced document is not physically located in the docket. For assistance

in locating these other documents, please consult the person listed under FOR

29

FURTHER INFORMATION CONTACT.

1. EPA. Strengthening Transparency in Regulatory Science; Proposed Rule.

Federal Register (83 FR18768, April 30, 2018) (FRL-9977-40).

2. EPA. Strengthening Transparency in Regulatory Science; Extension of

Comment Period and Notice of Public Hearing Federal Register (83 Fed. Reg. 24255,

May 25, 2018).

3. OMB (Office of Management and Budget). (2019). Improving Implementation

of the Information Quality Act. Memorandum for the Heads of Executive Departments

and Agencies. OMB Issuance M-19-15. Washington, DC: Executive Office of the

President. https://www.whitehouse.gov/wp-content/uploads/2019/04/M-19-15.pdf

4. OMB (Office of Management and Budget). (2004). Memorandum for the

Heads of Executive Departments and Agencies on Final Information Quality Bulletin for

Peer-Review.

https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/omb/memoranda/fy

2005/m05-03.pdf.

5. OMB (Office of Management and Budget). (2019). Executive Order 13891 of

October 9, 2019. Promoting the Rule of Law Through Improved Agency Guidance

Documents. 84 FR 199. https://www.govinfo.gov/content/pkg/FR-2019-10-15/pdf/2019-

22623.pdf.

6. NAS (National Academies of Sciences, Engineering, and Medicine). (2016).

Principles and obstacles for sharing data from environmental health research:

Workshop summary. Washington, DC: The National Academies Press.

https://doi.org/10.17226/21703.

30

7. Pellizzari, YE; Lohr, K, Blatecky, A.; Creel, D. (2017). Reproducibility: A Primer

on Semantics and Implications for Research. Research Triangle Park, NC: RTI Press.

8. Goodman, SN; Fanelli, D; Ioannidis, JPA. (2016). What does research

reproducibility mean? Sci Translational Medicine 8: 341ps12.

https://doi.org/10.1126/scitranslmed.aaf5027

9. OMB (Office of Management and Budget). (2002). Guidelines for Ensuring and

Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by

Federal Agencies; Final guidelines. 67 FR 8452-8460.

https://www.govinfo.gov/content/pkg/FR-2002-02-22/pdf/R2-59.pdf

10. OMB (Office of Management and Budget). (2013). Uniform Administrative

Requirements, Cost Principles, and Audit Requirements for Federal Awards; Final Rule.

78 FR 78589-78691. https://www.govinfo.gov/content/pkg/FR-2013-12-26/pdf/2013-

30465.pdf

11. U.S. EPA (U.S. Environmental Protection Agency). (2016). Plan to Increase

Access to Results of EPA-Funded Scientific Research. (EPA/601-R-16-005).

Washington, DC: U.S. Environmental Protection Agency.

https://www.epa.gov/sites/production/files/2016-

12/documents/epascientificresearchtransperancyplan.pdf

12. U.S. EPA (U.S. Environmental Protection Agency). (2009). Guidance on the

Development, Evaluations, and Application of Environmental Models. (EPA/100/K-

09/003). Washington, DC: US. Environmental Protection Agency.

https://www.epa.gov/sites/production/files/2015-04/documents/cred_guidance_0309.pdf

13. NRC (National Research Council). (2007). Models in Environmental

31

Regulatory Decision Making. Washington, DC: The National Academies Press.

https://doi.org/10.17226/11972

14. OMB (Office of Management and Budget). (2013). Memorandum for the

Heads of Executive Departments and Agencies on Open Data Policy—Managing

Information as an Asset (https://projectopen-data.cio.gov/policy-memo/).

15. CDC (Centers for Disease Control). Research Data Center.

https://www.cdc.gov/rdc/index.htm

VII. Statutory and Executive Order Reviews

Additional information about these statutes and Executive Orders can be found at

https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive Order

13563: Improving Regulation and Regulatory Review

This action is a significant regulatory action that was submitted to the Office of

Management and Budget (OMB) for review. Any changes made in response to OMB

recommendations have been documented in the docket.

B. Executive Order 13771: Reducing Regulations and Controlling Regulatory Costs

This action is not expected to be an Executive Order 13771 regulatory action

because it relates to ‘‘agency organization, management or personnel.’’

C. Paperwork Reduction Act (PRA)

This action does not contain any information collection activities and therefore

does not impose an information collection burden under the PRA.

D. Regulatory Flexibility Act (RFA)

I certify that this action will not have a significant economic impact on a

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substantial number of small entities under the RFA. This action will not impose any

requirements on small entities. This action does not regulate any entity outside the

federal government.

E. Unfunded Mandates Reform Act (UMRA)

This action does not contain any unfunded mandate as described in UMRA, 2

U.S.C. 1531–1538, and does not significantly or uniquely affect small governments. The

action imposes no enforceable duty on any state, local or tribal governments or the

private sector.

F. Executive Order 13132: Federalism

This action does not have federalism implications. It will not have substantial

direct effects on the states, on the relationship between the national government and

the states, or on the distribution of power and responsibilities among the various levels

of government.

G. Executive Order 13175: Consultation and Coordination With Indian Tribal

Governments

This action does not have tribal implications as specified in Executive Order

13175. Thus, Executive Order 13175 does not apply to this action.

H. Executive Order 13045: Protection of Children From Environmental Health Risks and

Safety Risks

The EPA interprets Executive Order 13045 as applying only to those regulatory

actions that concern environmental health or safety risks that the EPA has reason to

believe may disproportionately affect children, per the definition of ‘‘covered regulatory

action’’ in section 2–202 of the Executive Order. This action is not subject to Executive

33

Order 13045 because it does not concern an environmental health risk or safety risk.

I. Executive Order 13211: Actions Concerning Regulations That Significantly Affect

Energy Supply, Distribution or Use

This action is not a ‘‘significant energy action’’ because it is not likely to have a

significant adverse effect on the supply, distribution or use of energy.

J. National Technology Transfer and Advancement Act (NTTAA)

This rulemaking does not involve technical standards.

K. Executive Order 12898: Federal Actions To Address Environmental Justice in

Minority Populations and Low-Income Populations

The EPA believes that this action is not subject to Executive Order 12898 (59 FR

7629, February 16, 1994) because it does not establish an environmental health or

safety standard.

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List of Subjects in 40 CFR Part 30

Environmental protection, Administrative practice and procedure, Reporting and

recordkeeping requirements

Strengthening Transparency in Regulatory Science

Page XX of XX

Dated: __________________________________.

________________________________________

Andrew R. Wheeler, Administrator.

35

Therefore, 40 CFR part 30, as proposed to be added at 83 FR 18768 (April 30, 2018), is

proposed to be amended as follows:

PART 30—TRANSPARENCY IN REGULATORY DECISIONMAKING

1. The authority citation for part 30 is revised to read as follows:

Authority: 5 U.S.C. 301; 5 U.S.C. App.; Pub. L. 98-80, 84 Stat. 2086

2. Revise § 30.2 to add the following:

§ 30.2. What definitions apply to this subpart?

“Capable of being substantially reproduced” means that independent analysis of the

original or supporting data using identical methods would generate similar analytic

results, subject to an acceptable degree of imprecision or error.

Data means the set of recorded factual material commonly accepted in the scientific

community as necessary to validate research findings in which obvious errors, such as

keystroke or coding errors, have been removed and that is capable of being analyzed

by either the original researcher or an independent party.

Influential scientific information means scientific information the agency reasonably can

determine will have or does have a clear and substantial impact on important public

policies or private sector decisions.

Independent validation means the reanalysis of study data by subject matter experts

who have not contributed to the development of the study to demonstrate that the same

analytic results reported in the study are capable of being substantially reproduced.

Model means a simplification of reality that is constructed to gain insights into select

attributes of a physical, biological, economic, or social system. A formal representation

of the behavior of system processes, often in mathematical or statistical terms. The

36

basis can also be physical or conceptual.

Pivotal science means the specific scientific studies or analyses that underly influential

scientific information.

Publicly available means lawfully available to the general public from federal, state, or

local government records; the Internet; widely distributed media; or disclosures to the

general public that are required to be made by federal, state, or local law.

Reanalyze means to analyze exactly the same data to see if the same result emerges

from the analysis by using the same or different statistical software, models, and

statistical methodologies that were originally used to analyze the data, as well as to

assess potential analytical errors and variability in the underlying assumptions of the

original analysis.

3. Revise § 30.3 to read as follows:

§ 30.3 How do the provisions of this subpart apply?

The provisions of this subpart apply to data and models, underlying pivotal

science supporting influential scientific information and/or underlying pivotal regulatory

science used to justify significant regulatory decisions regardless of the source of

funding or identity of the party conducting the science. The provisions of this section do

not apply to physical objects (like laboratory samples), drafts, and preliminary analyses.

In the event the procedures outlined in this rule conflict with statutes that EPA

administers, or their implementing regulations, the statutes and regulations will control.

Except where explicitly stated otherwise, the provisions of this subpart do not apply to

any other type of agency action, including individual party adjudications, enforcement

activities, or permit proceedings.

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§ 30.5 [Reserved]

4. Revise § 30.5 to read as follows:

§ 30.5 What requirements apply to EPA’s use of data and models underlying

pivotal regulatory science and pivotal science?

When promulgating significant regulatory decisions or finalizing influential

scientific information, the Agency will only use pivotal regulatory science and/or pivotal

science that includes studies with restricted data and models (i.e., those that include

confidential business information (CBI), proprietary data, or Personally Identifiable

Information (PII) that cannot be sufficiently de-identified to protect the data subjects) if

there is tiered access to these data and models in a manner sufficient for independent

validation, and studies that do not include restricted data and models if the data and

models are publicly available in a manner sufficient for independent validation.

Where the Agency is making data or models publicly available, it shall do so in a

manner that is consistent with law, protects privacy, confidentiality, confidential business

information, and is sensitive to national and homeland security. Information is

considered ‘‘available in a manner sufficient for independent validation’’ when it includes

the information necessary to understand, assess, and reanalyze findings. This may

include, for example:

(a) Data (where necessary, data would be made available subject to access and use

restrictions);

(b) Associated protocols necessary to understand, assess, and extend conclusions;

(c) Computer codes and models involved in the creation and analysis of such

information;

38

(d) Recorded factual materials; and

(e) Detailed descriptions of how to access and use such information.

The provisions of this section apply to data and models underlying pivotal regulatory

science or pivotal science regardless of who funded or conducted the underlying data,

models, or other regulatory science or pivotal science. The agency shall make

reasonable efforts to explore methodologies, technologies, and institutional

arrangements for making such data and models available before it concludes that doing

so in a manner consistent with law and protection of privacy, confidentiality, national

and homeland security is not possible. Where data and models are controlled by third

parties, EPA may work with those parties to endeavor to make the data and models

available in a manner that complies with this section.

5. Revise § 30.5 to read as follows:

§ 30.5 What requirements apply to EPA’s use of data and models underlying

pivotal regulatory science and pivotal science? [ALTERNATE]

When promulgating significant regulatory decisions or finalizing influential

scientific information, the Agency will, other things equal, give greater consideration to

studies where the underlying data and models are publicly available in a manner

sufficient for independent validation. The Agency will also give greater consideration to

studies based on data and models that include confidential business information,

proprietary information or personally identifiable information if these data and models

were available through restricted access, such as through a secure data enclave, in a

manner sufficient for independent validation. Where there is no access to data and

models, or access is limited, the Agency may still consider these studies, depending on

39

the other attributes of the studies. Furthermore, the Agency will identify those studies

that are given greater consideration and provide a short description of why greater

consideration was given. Where the Agency is making data or models publicly available,

it shall do so in a manner that is consistent with law, protects privacy, confidentiality,

confidential business information, and is sensitive to national and homeland security.

Information is considered ‘‘available in a manner sufficient for independent validation’’

when it includes the information necessary to understand, assess, and reanalyze

findings. This may include, for example:

(a) Data (where necessary, data would be made available subject to access and use

restrictions);

(b) Associated protocols necessary to understand, assess, and extend conclusions;

(c) Computer codes and models involved in the creation and analysis of such

information;

(d) Recorded factual materials; and

(e) Detailed descriptions of how to access and use such information.

The provisions of this section apply to data and models underlying pivotal regulatory

science or pivotal science regardless of who funded or conducted the underlying data,

models, or other regulatory science or pivotal science. The agency shall make

reasonable efforts to explore methodologies, technologies, and institutional

arrangements for making such data and models available before it concludes that doing

so in a manner consistent with law and protection of privacy, confidentiality, national

and homeland security is not possible. Where data and models are controlled by third

parties, EPA may work with those parties to endeavor to make the data and models

40

available in a manner that complies with this section.

6. Revise § 30.6 to read as follows:

§ 30.6 What additional requirements pertain to the use of data and models

underlying pivotal science or pivotal regulatory science?

EPA shall describe and document any assumptions and methods used and shall

describe variability and uncertainty. EPA shall evaluate the appropriateness of using

default assumptions on a case-by-case basis. EPA shall clearly explain the scientific

basis for critical assumptions used in the analysis that drove the analytical results and

subsequent decisions and shall present analyses showing the sensitivity of the modeled

results to alternative assumptions. When available, EPA shall give explicit consideration

to high quality studies, including but not limited to those that explore: A broad class of

parametric dose-response or concentration-response models; a robust set of potential

confounding variables; nonparametric models that incorporate fewer assumptions;

various threshold models across the dose or exposure range; and models that

investigate factors that might account for spatial heterogeneity.

7. Revise § 30.7 to read as follows:

§ 30.7 What role does independent peer review have in this section?

EPA shall conduct independent peer review on all pivotal regulatory science

used to justify significant regulatory decisions and on all pivotal science underlying

influential scientific information, consistent with the requirements of the OMB Final

Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions

described therein. Because transparency in regulatory science includes addressing

issues associated with assumptions used in models, EPA shall ask peer reviewers to

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articulate the strengths and weaknesses of EPA’s justification for the assumptions

applied and the implications of those assumptions for the results.

8. Revise § 30.9 to read as follows:

§ 30.9 May the EPA Administrator grant exemptions to this subpart?

The Administrator may grant an exemption to this subpart on a case-by case

basis if he or she determines that compliance is impracticable because technological

barriers render sharing of the data or models infeasible, the development of the data or

model was completed or updated before [EFFECTIVE DATE OF FINAL RULE] or

making the data and models publicly available would conflict with laws governing

privacy, confidentiality, confidential business information, or national and homeland

security.